Comparative fasting bioavailability of 2 different betahistine dihydrochloride 24-mg tablets: a single-dose, randomized-sequence, open-label, 2-period crossover study in healthy Thai volunteers.
Not Applicable
Completed
- Conditions
- healthy volunteersbetahistine dihydrochlorideBioequivalence
- Registration Number
- TCTR20151106002
- Lead Sponsor
- Somruedee Chatsiricharoenkul
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
Healthy Thai volunteers with a body mass index between 18-25 kg/m2
In good physical condition by clinical screening included history taking, physical examination and the following laboratory tests: complete blood count, blood urea nitrogen, serum creatinine, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, fasting blood sugar, urinalysis and hepatitis B surface antigen.
Exclusion Criteria
- Pregnant or lactating women or positive pregnancy test women
- Allergy to the study drug
- Volunteers who used any drugs, food supplements, vitamins, mineral, herbal remedies, contraceptives hormonal within 14 days before study participation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Plasma concentrations of 2-pyridylacetic acid (2-PAA), a major metabolite of betahistine Blood samples were obtained at pre-dose and over 14 hours after dosing. liquid chromatography with tandem mass spectrometry (LC-MS/MS)
- Secondary Outcome Measures
Name Time Method Tolerability throughout the study Adverse events were monitored and recorded based on volunteer interview and physical examination.